CRA II / Sr. CRA – Oncology
Hybrid based. Oncology experience essential.
Job Summary
Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials.
Responsibilities
* Perform site qualification, site initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
* Verify informed consent process and protect subject confidentiality, assessing safety and data integrity at investigator sites.
* Assess site processes, conduct source document review, verify CRF data accuracy, resolve inquiries, and support query resolution within agreed timelines.
* Perform investigational product inventory, reconciliation, and review of storage/security; ensure appropriate labeling, import/export, release/return.
* Review Investigator Site File accuracy, reconcile with Trial Master File, and advise on archiving requirements.
* Document activities and communicate via letters, reports, logs and other SOP‑compliant records; support recruitment, retention, and awareness strategies.
* Manage site‑level activities, budgets and timelines; adapt quickly to changing priorities and meet project objectives.
* Act as primary liaison with study site personnel, ensuring training and compliance; collaborate with central monitoring associates.
* Prepare for and attend investigator meetings, sponsor meetings, and global clinical monitoring/project staff meetings.
* Provide guidance towards audit readiness and support audit preparation and follow‑up actions.
* Maintain ICH/GCP and other regulatory knowledge, complete required training, and collaborate with sponsor affiliates, medical science liaisons, and local country staff.
Impact & Contribution
Individual contributors manage key components of projects, direct lower‑level professionals, and design, implement, or deliver processes and policies. The majority of time is devoted to process development, project management, and policy implementation using advanced education and experience.
Qualifications
* Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
* Knowledge of Good Clinical Practice / ICH Guidelines and other applicable regulatory requirements.
* Strong computer skills and ability to embrace new technologies.
* Excellent communication, presentation, and interpersonal skills.
* Ability to manage required travel up to 75% on a regular basis.
* US ONLY: employee privacy notice compliance and confidentiality disclosure requirements.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations when appropriate.
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